Drug Evaluation Committee Innovative Changes in Data Management Introduction to the SCDM Reflection Papers: "The Evolution of Clinical Data Management to Clinical Data Science"
November 2020
Clinical trials are undergoing a transformation in trial design, and the technologies that can and should be utilized are evolving. Furthermore, the range of considerations and challenges that must be addressed—such as regulatory requirements and the quality standards demanded in clinical trials—is diversifying.
In light of the above, this article introduces the “Reflection Papers: The Evolution of Clinical Data Management to Clinical Data Science,” released by the Society for Clinical Data Management (SCDM) released in June 2019 (first edition) and March 2020 (Part 2).
Please note that this document is a slide-based presentation focused exclusively on introducing the SCDM Reflection Papers, released with the aim of providing timely information amid the urgent need for transformation in data management due to the impact of COVID-19. The views of the JPMA are not included in this document, and we plan to continue discussing specific challenges and countermeasures.